Pilot Study: Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Prevention

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary aim of the pilot study is to provide data that can be used to better determine sample size for the design of a larger clinical trial. The pilot will evaluate the effectiveness of Lipoic Acid (LA) plus Omega-3 fatty acids (Omega-3) on preventing Alzheimer's Disease (AD). The investigators will also collect data to evaluate recruitment rate, safety, and compliance over the 12 month study period.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Treatments: Thioctic Acid

Criteria

Inclusion Criteria:

• 55 years or older

• Non-demented: Montreal Cognitive Assessment > 26 and Clinical Dementia Rating = 0

• Diagnosis of Essential Hypertension with systolic 90-160 mm Hg and diastolic 60-90 mm Hg

• Stable dose of antihypertensive medication 4 month prior to study enrollment

• Stable dose of lipid lowering medication - dose must be stable for 4 months prior to study enrollment

• Low Omega-3 fatty acid Status: Omega-3 index, < 4% of total fatty acid of combined docosahexaenoic acid and eicosapentanoic acid

• Geriatric Depression Scale < 5

• General health status that will not interfere with the participant's ability to complete the study.

• Screening laboratory values within normal limits or, if abnormal, deemed clinically insignificant by the investigator

• Sufficient English language skills to complete all testing

Exclusion Criteria:

• Alzheimer's, Dementia or other neurodegenerative disease.

• Health conditions such as cancer diagnosed < 5 years prior to enrollment (prostate cancer gleason grade < 3 and non metastatic skin cancers are acceptable), liver disease, history of ventricular fibrillation or ventricular tachycardia, major psychiatric disorder, central nervous system diseases (e.g. brain tumor, seizure disorder)

• Insulin dependent diabetes or uncontrolled diabetes (diabetes controlled on medications other than insulin are acceptable)

• Fish intake of one 6 ounce serving > once a week less than 4 months prior to enrollment

• Omega-3 fatty acid supplement intake (e.g. fish oil capsules, cod liver oil) less than 4 months prior to enrollment

• Lipoic Acid supplementation less than 1 month prior to enrollment

• Taking systemic corticosteroids, neuroleptics, antiparkinsonian agents, and/or narcotic analgesics. Low dose sinemet and dopamine agonist taken once a day for restless leg syndrome is not an exclusion.

• Contraindications to MRI, including: subjects with intrathecal pumps, stimulators, pacemakers, aneurysm clips, non-removable hearing aids, or metal fragments in the eyes. Other exclusion criteria include the inability to lie flat on the back for 40 minutes at a time or a self-reported history of claustrophobia. Subjects with a history of hip replacement and those with well-documented, verifiable, MRI-safe cardiac stents will not be excluded from the study.

• Enrollment in another treatment study